System and method for identifying availability of clinician defined programming settings for a patient

ABSTRACT

An external control device for indicating whether a stimulation parameter set for use in a neurostimulator is available on a remote control in communication with the external control device is provided. The device includes a user interface configured for displaying the stimulation parameter set and an indicator that indicates whether the stimulation parameter set is available to the patient from the remote control. The device also includes control circuitry configured for, in response to input from the user (e.g., actuating the indicator), selectively turning the indicator on or off. The indicator may be an icon, and the icon may be a graphical depiction of a remote control. The user interface may be further configured for receiving additional input from the user, and the control circuitry may be further configured for, in response to the additional input from the user, programming the remote control with the stimulation parameter set.

RELATED APPLICATION DATA

The present application claims the benefit under 35 U.S.C. § 119 to U.S.provisional patent application Ser. No. 61/694,702, filed Aug. 29, 2012.The foregoing application is hereby incorporated by reference into thepresent application in its entirety.

FIELD OF THE INVENTION

The present invention relates to tissue stimulation systems, and moreparticularly, to a system and method for programming an implantabletissue stimulator.

BACKGROUND OF THE INVENTION

Implantable neurostimulation systems have proven therapeutic in a widevariety of diseases and disorders. Pacemakers and Implantable CardiacDefibrillators (ICDs) have proven highly effective in the treatment of anumber of cardiac conditions (e.g., arrhythmias). Spinal CordStimulation (SCS) systems have long been accepted as a therapeuticmodality for the treatment of chronic pain syndromes, and theapplication of tissue stimulation has begun to expand to additionalapplications such as angina pectoralis and incontinence. Deep BrainStimulation (DBS) has also been applied therapeutically for well over adecade for the treatment of refractory chronic pain syndromes, and DBShas also recently been applied in additional areas such as movementdisorders and epilepsy. Further, in recent investigations, PeripheralNerve Stimulation (PNS) systems have demonstrated efficacy in thetreatment of chronic pain syndromes and incontinence, and a number ofadditional applications are currently under investigation. Also,Functional Electrical Stimulation (FES) systems such as the Freehandsystem by NeuroControl (Cleveland, Ohio) have been applied to restoresome functionality to paralyzed extremities in spinal cord injurypatients.

These implantable neurostimulation systems typically include one or moreelectrode carrying neurostimulation leads, which are implanted at thedesired stimulation site, and a neurostimulator (e.g., an implantablepulse generator (IPG)) implanted remotely from the stimulation site, butcoupled either directly to the neurostimulation lead(s) or indirectly tothe neurostimulation lead(s) via a lead extension. Thus, electricalpulses can be delivered from the neurostimulator to the neurostimulationleads to stimulate the tissue and provide the desired efficacioustherapy to the patient.

The combination of electrodes used to deliver electrical pulses to thetargeted tissue constitutes an electrode combination, with theelectrodes capable of being selectively programmed to act as anodes(positive), cathodes (negative), or left off (zero). In other words, anelectrode combination represents the polarity being positive, negative,or zero. Other parameters that may be controlled or varied include theamplitude, width, and rate of the electrical pulses provided through theelectrode array. Each electrode combination, along with the electricalpulse parameters, can be referred to as a “stimulation parameter set.”

The neurostimulation system may further include a handheld patientprogrammer in the form of a remote control (RC) to remotely instruct theneurostimulator to generate electrical stimulation pulses in accordancewith selected stimulation parameters. The RC may, itself, be programmedby a clinician, for example, by using a clinician's programmer (CP),which typically includes a general purpose computer, such as a laptop,with a programming software package installed thereon.

During programming, the clinician may use the CP to test severaldifferent stimulation parameter sets. In a typical scenario, theclinician utilizes a “stimulation parameter testing” screen of the CP totest the various stimulation parameter sets, and then, once the optimumor most effective stimulation parameter sets are determined, they areprogrammed into the IPG. Various stimulation parameter sets, alsoreferred to as “areas,” may be combined into a stimulation program thatcan be stored in the IPG. For example, four stimulation parameter setsmay be combined into a single stimulation program, which, when operatedvia prompting by the RC, outputs four electrical pulse trains inaccordance with the respective stimulation parameter sets via multipletiming channels. Although the IPG may be programmed with a stimulationprogram containing a number of stimulation parameter sets, not all ofthese stimulation parameter sets may be available to the patient. Inparticular, the RC may be programmed in a manner that prevents thepatient from operating certain selected stimulation parameter sets thathave been stored in the IPG. However, there is no easy way for theclinician to determine which of the stimulation parameter sets isavailable to the patient from the RC.

There, thus, remains a need to provide a user interface capable ofeasily and conveniently identifying those stimulation parameter setsthat have already been made available through the RC, and capable ofeasily and conveniently indicating which stimulation parameter setsshould be made available or unavailable through the RC.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present inventions, an externalcontrol device for indicating whether a stimulation parameter set foruse in a neurostimulator is available on a remote control incommunication with the external control device is provided. The externalcontrol device includes a user interface configured for receiving inputfrom a user, for displaying the stimulation parameter set, and fordisplaying an indicator that indicates whether the stimulation parameterset is available to the patient from the remote control. The indicatormay be an icon, and the icon may be a graphical depiction of a remotecontrol. The user interface may include a mouse, a trackball, atouchpad, and/or a joystick for receiving the input from the user. Theuser interface may include a digitizer screen for receiving the inputfrom the user.

The external control device also includes control circuitry configuredfor, in response to input from the user (e.g., actuating the indicator),selectively turning the indicator on or off. The user interface may befurther configured for receiving additional input from the user, and thecontrol circuitry may be further configured for, in response to theadditional input from the user, programming the remote control with thestimulation parameter set. The control circuitry may be furtherconfigured for, in response to the additional input from the user,programming the neurostimulator and/or remote control with thestimulation parameter set. The user interface may be configured fordisplaying a plurality of stimulation parameter sets and a respectiveplurality of indicators, each indicating whether the respectivestimulation parameter set is available to the patient from the remotecontrol, wherein the control circuitry may be further configured for, inresponse to input from the user, selectively turning each of theindicators on or off. The control circuitry may be configured forprogramming the plurality of stimulation parameter sets within a singleprogram into the remote control.

Other and further aspects and features of the invention will be evidentfrom reading the following detailed description of the preferredembodiments, which are intended to illustrate, not limit, the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate the design and utility of preferred embodimentsof the present invention, in which similar elements are referred to bycommon reference numerals. In order to better appreciate how theabove-recited and other advantages and objects of the present inventionsare obtained, a more particular description of the present inventionsbriefly described above will be rendered by reference to specificembodiments thereof, which are illustrated in the accompanying drawings.Understanding that these drawings depict only typical embodiments of theinvention and are not therefore to be considered limiting of its scope,the invention will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is perspective view of one embodiment of a SCS system arranged inaccordance with the present inventions;

FIG. 2 is a plan view of the SCS system of FIG. 1 in use with a patient;

FIG. 3 is a side view of an implantable pulse generator and a pair ofstimulation leads that can be used in the SCS system of FIG. 1;

FIG. 4 is a plan view of a remote control that can be used in the SCSsystem of FIG. 1;

FIG. 5 is a block diagram of the internal componentry of the remotecontrol of FIG. 4;

FIG. 6 is a block diagram of the components of a clinician programmerthat can be used in the SCS system of FIG. 1; and

FIG. 7 is a plan view of a user interface of the CP of FIG. 6 forprogramming the IPG of FIG. 3 in a manual mode;

FIG. 8 is a plan view of a user interface of the CP of FIG. 6 forprogramming the IPG of FIG. 3 in an e-troll mode;

FIG. 9 is a plan view of the user interface of FIG. 8, particularlyshowing the expansion of the Advanced Tab into resolution and focuscontrols; and

FIG. 10 is a plan view of a user interface of the CP of FIG. 6 forprogramming the IPG of FIG. 3 in a Navigation mode.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The description that follows relates to a spinal cord stimulation (SCS)system. However, it is to be understood that the while the inventionlends itself well to applications in SCS, the invention, in its broadestaspects, may not be so limited. Rather, the invention may be used withany type of implantable electrical circuitry used to stimulate tissue.For example, the present invention may be used as part of a pacemaker, adefibrillator, a cochlear stimulator, a retinal stimulator, a stimulatorconfigured to produce coordinated limb movement, a cortical stimulator,a deep brain stimulator, peripheral nerve stimulator, microstimulator,or in any other neural stimulator configured to treat urinaryincontinence, sleep apnea, shoulder sublaxation, headache, etc.

Turning first to FIG. 1, an exemplary SCS system 10 generally includes aplurality (in this case, two) of implantable neurostimulation leads 12,an implantable pulse generator (IPG) 14, an external remote controller(RC) 16, a clinician's programmer (CP) 18, an external trial stimulator(ETS) 20, and an external charger 22.

The IPG 14 is physically connected via one or more percutaneous leadextensions 24 to the neurostimulation leads 12, which carry a pluralityof electrodes 26 arranged in an array. In the illustrated embodiment,the neurostimulation leads 12 are percutaneous leads, and to this end,the electrodes 26 are arranged in-line along the neurostimulation leads12. The number of neurostimulation leads 12 illustrated is two, althoughany suitable number of neurostimulation leads 12 can be provided,including only one. Alternatively, a surgical paddle lead in can be usedin place of one or more of the percutaneous leads. As will be describedin further detail below, the IPG 14 includes pulse generation circuitrythat delivers electrical stimulation energy in the form of a pulsedelectrical waveform (i.e., a temporal series of electrical pulses) tothe electrode array 26 in accordance with a set of stimulationparameters.

The ETS 20 may also be physically connected via percutaneous leadextensions 28 and/or an external cable 30 to the neurostimulation leads12. The ETS 20, which has pulse generation circuitry similar to that ofthe IPG 14, also delivers electrical stimulation energy in the form of apulsed electrical waveform to the electrode array 26 accordance with aset of stimulation parameters. The major difference between the ETS 20and the IPG 14 is that the ETS 20 is a non-implantable device that isused on a trial basis after the neurostimulation leads 12 have beenimplanted and prior to implantation of the IPG 14, to test theresponsiveness of the stimulation that is to be provided. Thus, anyfunctions described herein with respect to the IPG 14 can likewise beperformed with respect to the ETS 20. Further details of an exemplaryETS are described in U.S. Pat. No. 6,895,280, which is expresslyincorporated herein by reference.

The RC 16 may be used to telemetrically control the ETS 20 via abi-directional RF communications link 32. Once the IPG 14 andneurostimulation leads 12 are implanted, the RC 16 may be used totelemetrically control the IPG 14 via a bi-directional RF communicationslink 34. Such control allows the IPG 14 to be turned on or off and to beprogrammed with different stimulation parameter sets. The IPG 14 mayalso be operated to modify the programmed stimulation parameters toactively control the characteristics of the electrical stimulationenergy output by the IPG 14. As will be described in further detailbelow, the CP 18 provides clinician detailed stimulation parameters forprogramming the IPG 14 and ETS 20 in the operating room and in follow-upsessions.

The CP 18 may perform this function by indirectly communicating with theIPG 14 or ETS 20, through the RC 16, via an IR communications link 36.Alternatively, the CP 18 may directly communicate with the IPG 14 or ETS20 via an RF communications link (not shown). The clinician detailedstimulation parameters provided by the CP 18 are also used to programthe RC 16, so that the stimulation parameters can be subsequentlymodified by operation of the RC 16 in a stand-alone mode (i.e., withoutthe assistance of the CP 18).

The external charger 22 is a portable device used to transcutaneouslycharge the IPG 14 via an inductive link 38. For purposes of brevity, thedetails of the external charger 22 will not be described herein. Detailsof exemplary embodiments of external chargers are disclosed in U.S. Pat.No. 6,895,280, which has been previously incorporated herein byreference. Once the IPG 14 has been programmed, and its power source hasbeen charged by the external charger 22 or otherwise replenished, theIPG 14 may function as programmed without the RC 16 or CP 18 beingpresent.

As shown in FIG. 2, the neurostimulation leads 12 are implanted withinthe spinal column 42 of a patient 40. The preferred placement of theneurostimulation leads 12 is adjacent, i.e., resting upon, the spinalcord area to be stimulated. Due to the lack of space near the locationwhere the neurostimulation leads 12 exit the spinal column 42, the IPG14 is generally implanted in a surgically-made pocket either in theabdomen or above the buttocks. The IPG 14 may, of course, also beimplanted in other locations of the patient's body. The lead extension24 facilitates locating the IPG 14 away from the exit point of theneurostimulation leads 12. As there shown, the CP 18 communicates withthe IPG 14 via the RC 16.

Referring now to FIG. 3, the external features of the neurostimulationleads 12 and the IPG 14 will be briefly described. One of theneurostimulation leads 12(1) has eight electrodes 26 (labeled E1-E8),and the other stimulation lead 12(2) has eight electrodes 26 (labeledE9-E16). The actual number and shape of leads and electrodes will, ofcourse, vary according to the intended application. The IPG 14 comprisesan outer case 50 for housing the electronic and other components(described in further detail below), and a connector 52 to which theproximal ends of the neurostimulation leads 12 mate in a manner thatelectrically couples the electrodes 26 to the electronics within theouter case 50. The outer case 50 is composed of an electricallyconductive, biocompatible material, such as titanium, and forms ahermetically sealed compartment wherein the internal electronics areprotected from the body tissue and fluids. In some cases, the outer case50 may serve as an electrode.

The IPG 14 includes a battery and pulse generation circuitry thatdelivers the electrical stimulation energy in the form of a pulsedelectrical waveform to the electrode array 26 in accordance with a setof stimulation parameters programmed into the IPG 14. Such stimulationparameters may comprise electrode combinations, which define theelectrodes that are activated as anodes (positive), cathodes (negative),and turned off (zero), percentage of stimulation energy assigned to eachelectrode (fractionalized electrode configurations), and electricalpulse parameters, which define the pulse amplitude (measured inmilliamps or volts depending on whether the IPG 14 supplies constantcurrent or constant voltage to the electrode array 26), pulse width(measured in microseconds), and pulse rate (measured in pulses persecond).

Electrical stimulation will occur between two (or more) activatedelectrodes, one of which may be the IPG case 50. Simulation energy maybe transmitted to the tissue in a monopolar or multipolar (e.g.,bipolar, tripolar, etc.) fashion. Monopolar stimulation occurs when aselected one of the lead electrodes 26 is activated along with the case50 of the IPG 14, so that stimulation energy is transmitted between theselected electrode 26 and case 50. Bipolar stimulation occurs when twoof the lead electrodes 26 are activated as anode and cathode, so thatstimulation energy is transmitted between the selected electrodes 26.For example, electrode E3 on the first lead 12(1) may be activated as ananode at the same time that electrode E11 on the second lead 12(2) isactivated as a cathode. Tripolar stimulation occurs when three of thelead electrodes 26 are activated, two as anodes and the remaining one asa cathode, or two as cathodes and the remaining one as an anode. Forexample, electrodes E4 and E5 on the first lead 12(1) may be activatedas anodes at the same time that electrode E12 on the second lead 12(2)is activated as a cathode.

In the illustrated embodiment, the IPG 14 can individually control themagnitude of electrical current flowing through each of the electrodes.In this case, it is preferred to have a current generator, whereinindividual current-regulated amplitudes from independent current sourcesfor each electrode may be selectively generated. Although this system isoptimal to take advantage of the invention, other stimulators that maybe used with the invention include stimulators having voltage regulatedoutputs. While individually programmable electrode amplitudes areoptimal to achieve fine control, a single output source switched acrosselectrodes may also be used, although with less fine control inprogramming. Mixed current and voltage regulated devices may also beused with the invention. Further details discussing the detailedstructure and function of IPGs are described more fully in U.S. Pat.Nos. 6,516,227 and 6,993,384, which are expressly incorporated herein byreference.

It should be noted that rather than an IPG, the SCS system 10 mayalternatively utilize an implantable receiver-stimulator (not shown)connected to the neurostimulation leads 12. In this case, the powersource, e.g., a battery, for powering the implanted receiver, as well ascontrol circuitry to command the receiver-stimulator, will be containedin an external controller inductively coupled to the receiver-stimulatorvia an electromagnetic link. Data/power signals are transcutaneouslycoupled from a cable-connected transmission coil placed over theimplanted receiver-stimulator. The implanted receiver-stimulatorreceives the signal and generates the stimulation in accordance with thecontrol signals.

Referring now to FIG. 4, one exemplary embodiment of an RC 16 will nowbe described. As previously discussed, the RC 16 is capable ofcommunicating with the IPG 14, CP 18, or ETS 20. The RC 16 comprises acasing 51, which houses internal componentry (including a printedcircuit board (PCB)), and a lighted display screen 53 and button pad 54carried by the exterior of the casing 51. In the illustrated embodiment,the display screen 53 is a lighted flat panel display screen, and thebutton pad 54 comprises a membrane switch with metal domes positionedover a flex circuit, and a keypad connector connected directly to a PCB.In an optional embodiment, the display screen 53 has touchscreencapabilities. The button pad 54 includes a multitude of buttons 56, 58,60, and 62, which allow the IPG 14 to be turned ON and OFF, provide forthe adjustment or setting of stimulation parameters within the IPG 14,and provide for selection between screens. Further details of thefunctionality and internal componentry of the RC 16 are disclosed inU.S. Pat. No. 6,895,280, which has previously been incorporated hereinby reference.

Referring to FIG. 5, the internal components of an exemplary RC 16 willnow be described. The RC 16 generally includes a processor 64 (e.g., amicrocontroller), memory 66 that stores an operating program forexecution by the processor 64, as well as stimulation parameter sets,input/output circuitry, and in particular, telemetry circuitry 68 foroutputting stimulation parameters to the IPG 14 and receiving statusinformation from the IPG 14, and input/output circuitry 70 for receivingstimulation control signals from the button pad 54 and transmittingstatus information to the display screen 52 (shown in FIG. 4). As wellas controlling other functions of the RC 16, which will not be describedherein for purposes of brevity, the processor 64 generates newstimulation parameter sets in response to the user operation of thebutton pad 54. These new stimulation parameter sets would then betransmitted to the IPG 14 via the telemetry circuitry 68. Furtherdetails of the functionality and internal componentry of the RC 16 aredisclosed in U.S. Pat. No. 6,895,280, which has previously beenincorporated herein by reference.

As briefly discussed above, the CP 18 greatly simplifies the programmingof multiple electrode combinations, allowing the user (e.g., thephysician or clinician) to readily determine the desired stimulationparameters to be programmed into the IPG 14, as well as the RC 16. Thus,modification of the stimulation parameters in the programmable memory ofthe IPG 14 after implantation is performed by a user using the CP 18,which can directly communicate with the IPG 14 or indirectly communicatewith the IPG 14 via the RC 16. That is, the CP 18 can be used by theuser to modify operating parameters of the electrode array 26 near thespinal cord.

As shown in FIG. 2, the overall appearance of the CP 18 is that of alaptop personal computer (PC), and in fact, may be implemented using aPC that has been appropriately configured to include adirectional-programming device and programmed to perform the functionsdescribed herein. Alternatively, the CP 18 may take the form of amini-computer, personal digital assistant (PDA), etc., or even a remotecontrol (RC) with expanded functionality. Thus, the programmingmethodologies can be performed by executing software instructionscontained within the CP 18. Alternatively, such programmingmethodologies can be performed using firmware or hardware. In any event,the CP 18 may actively control the characteristics of the electricalstimulation generated by the IPG 14 to allow the optimum stimulationparameters to be determined based on patient feedback and forsubsequently programming the IPG 14 with the optimum stimulationparameters.

To allow the user to perform these functions, the CP 18 includes a userinterface. In the illustrated embodiment, the user interface of the CP18 includes a mouse 72, a keyboard 74, and a programming display screen76 housed in a case 78. It is to be understood that in addition to, orin lieu of, the mouse 72, other directional programming devices may beused, such as a trackball, touchpad, joystick, or directional keysincluded as part of the keys associated with the keyboard 74.

In the illustrated embodiment described below, the display screen 76takes the form of a conventional screen, in which case, a virtualpointing device, such as a cursor controlled by a mouse, joy stick,trackball, etc, can be used to manipulate graphical objects on thedisplay screen 76. In alternative embodiments, the display screen 76takes the form of a digitizer touch screen, which may be either passiveor active. If passive, the display screen 76 includes detectioncircuitry that recognizes pressure or a change in an electrical currentwhen a passive device, such as a finger or non-electronic stylus,contacts the screen. If active, the display screen 76 includes detectioncircuitry that recognizes a signal transmitted by an electronic pen orstylus. In either case, detection circuitry is capable of detecting whena physical pointing device (e.g., a finger, a non-electronic stylus, oran electronic stylus) is in close proximity to the screen, whether it bemaking physical contact between the pointing device and the screen orbringing the pointing device in proximity to the screen within apredetermined distance, as well as detecting the location of the screenin which the physical pointing device is in close proximity. When thepointing device touches or otherwise is in close proximity to thescreen, the graphical object on the screen adjacent to the touch pointis “locked” for manipulation, and when the pointing device is moved awayfrom the screen the previously locked object is unlocked.

As shown in FIG. 6, the CP 18 generally includes control circuitry 80(e.g., a central processor unit (CPU)) and memory 82 that stores astimulation programming package 84, which can be executed by the controlcircuitry 80 to allow the user to program the IPG 14, and RC 16. The CP18 further includes output circuitry 86 for downloading (e.g., via thetelemetry circuitry of the RC 16) stimulation parameters to the IPG 14and RC 16 and for uploading stimulation parameters already stored in thememory 66 of the RC 16, via the telemetry circuitry 68 of the RC 16.

Execution of the programming package 84 by the control circuitry 80provides a multitude of display screens (not shown) that can benavigated through via use of the pointing device. These display screensallow the clinician to, among other functions, select or enter patientprofile information (e.g., name, birth date, patient identification,physician, diagnosis, and address), enter procedure information (e.g.,programming/follow-up, implant trial system, implant IPG, implant IPGand lead(s), replace IPG, replace IPG and leads, replace or reviseleads, explant, etc.), generate a pain map of the patient, define theconfiguration and orientation of the leads, initiate and control theelectrical stimulation energy output by the neurostimulation leads 12,and select and program the IPG 14 with stimulation parameters in both asurgical setting and a clinical setting. Further details discussing theabove-described CP functions are disclosed in U.S. Patent ApplicationPublication No. 2010/0010566, entitled “System and Method for ConvertingTissue Stimulation Programs in a Format Usable by an Electrical CurrentSteering Navigator,” and U.S. Patent Application Publication No.2010/0121409, entitled “System and Method for Determining AppropriateSteering Tables for Distributing Stimulation Energy Among MultipleNeurostimulation Electrodes,” which are expressly incorporated herein byreference.

Most pertinent to the present inventions, execution of the programmingpackage 84 provides a user interface that conveniently displaysstimulation parameter sets along with indicators that indicate whethereach stimulation parameter set is available to the patient from the RC16. Thus, a user can quickly, easily, and conveniently determine rightfrom the user interface whether a stimulation parameter set is availableto the patient via the RC 16. Further, from the user interface, the usercan quickly, easily, and conveniently instruct the control circuitry 80to make a previously unavailable stimulation parameter set available tothe patient via the RC 16, and/or to make a previously availablestimulation parameter set unavailable to the patient.

Referring now to FIG. 7, a graphical user interface (GUI) 100 that canbe generated by the CP 18 to allow a user to program the IPG 14 will bedescribed. In the illustrated embodiment, the GUI 100 comprises threepanels: a program selection panel 102, a lead display panel 104, and anelectrical parameter adjustment panel 106. Some embodiments of the GUI100 may allow for closing and expanding one or both of the lead displaypanel 104 and the parameter adjustment panel 106 by clicking on the tab108 (to show or hide the parameter adjustment panel 106) or the tab 110(to show or hide the full view of both the lead display panel 104 andthe parameter adjustment panel 106).

The program selection panel 102 provides information about programs andareas that have been, or may be, defined for the IPG 14. A plurality ofprograms may be displayed in carousel 112. In the illustratedembodiment, sixteen programs may be defined, but program 1 is the onlyone currently defined, as shown by the “1” in field 114. Otherembodiments may use a carousel or other techniques for displayingavailable programs with different numbers or arrangements of availableprogram slots.

Each program may be named, as indicated by the name field 116. Astimulation on/off button 118 allows turning the currently activeprogram on or off. When the active program is on, stimulation parametersets will be generated in the CP 18 and transmitted to the RC 16. Up tofour program areas 120 may be defined, allowing a program to controlstimulation of multiple areas. Each program area 120 may separatelycontrol stimulation of electrodes in the patient, and may be separatelyturned on or off. Each of the program areas 120 may be labeled with alabel 122 that may be used as a marker on the graphical leads 124 and126, as described below. A number of temporary areas 128 may be used fortemporary storage of area information by copying a program area 120 intoa temporary area 128 or copying a temporary area 128 into a program area120. This allows copying a program area 120 from one of the four slotsto another slot via one of the temporary areas 128. Other embodimentsmay also allow copying one of the program areas 120 into another one ofthe program areas 120 directly. Individual programs may be copied toother slots in the carousel 112 or deleted as desired.

Each of the program areas 120 includes a stimulation parameter set 121.An indicator 123 is displayed along with each stimulation parameter set121, such that each displayed stimulation parameter set 121 isassociated with an indicator 123 that can selectively be turned on oroff by the user. In the embodiment shown in FIG. 7, each indicator 123is an icon, which is a graphical depiction of a remote control. However,it should be well understood that the indicator may alternatively be anyshape or format that may be selectively actuated by the user in order toturn the indicator on or off. For example, the indicator may be a radiobutton, check box, or the like.

The indicator 123 being on, actuated, or highlighted, as shown in “AreaA” and “Area B” of the exemplary GUI 100, indicates that the stimulationparameter set 121 associated with the indicator 123 is currentlyavailable, or is to be made available, to the patient via the RC 16. Theindicator 123 being off, un-actuated, un-highlighted, or grayed out, asshown in “Area C” and “Area D” of the exemplary GUI 100, indicates thatthe stimulation parameter set 121 associated with the indicator 123 iscurrently unavailable, or is to be made unavailable, to the patient viathe RC 16. When a stimulation parameter set 121 is not available to thepatient via the RC 16, that stimulation parameter set 121 may still beprogrammed into the IPG 14, but “locked” at the RC 16 to make itunavailable to the patient. For example, the program including all fourstimulation parameter sets 121 may be programmed into the RC 16.However, only those stimulation parameter sets 121 associated with anindicator 123 that has been turned on (e.g., Area A and Area B shown inFIG. 7) will be made available to the patient via the RC 16. Thosestimulation parameter sets 121 associated with an indicator 123 that hasbeen turned off (e.g., Area C and Area D shown in FIG. 7) will be madeunavailable to the patient from the RC 16 by “locking” them.Alternatively, a stimulation parameter set 121 may be made unavailableto the patient from the RC 16 by not programming the stimulationparameter set 121 into the IPG 14 at all.

From the GUI 100, a clinician may actuate the indicator 123 using apointing device (e.g., a cursor, finger, stylus, etc.), therebyselectively turning the indicator 123 on or off. By actuating anindicator 123 that is already on, the user turns the indicator 123 off,thereby instructing the control circuitry 80 to make a previouslyavailable stimulation parameter set 121 unavailable to the patient fromthe RC 16. By actuating an indicator 123 that is already off, the userturns the indicator 108 on, thereby instructing the control circuitry 80to make a previously unavailable stimulation parameter set 121 availableto the patient from the RC 16.

In response to additional input from the clinician, the controlcircuitry 80 is configured to program the IPG 14 with all of thestimulation parameter sets 121 displayed on the GUI 100. The controlcircuitry 80 is further configured for making available to the patientvia the RC 16 only those stimulation parameter sets 121 programmed intothe RC 16 that are associated with an indicator 123 that has been turnedon. Alternatively, rather than programming the IPG 14 with stimulationparameter sets, the control circuitry 80 may be configured to programthe RC 16 with only those stimulation parameter sets 121 associated withan indicator 123 that has been turned on.

Turning now to the lead display panel 104, graphical leads 124 and 126are illustrated with eight graphical electrodes 130 each (labeledelectrodes E1-E8 for lead 124 and electrodes E9-E16 for lead 126). Othernumbers of leads and electrodes per lead may be displayed as desired. Inan implanted system using other numbers of electrodes, that number ofelectrodes may be shown in lead display panel 104. Up to four groups ofleads may be viewed by selecting one of the lead group tabs 132. Inaddition, an icon 134 representing the case 50 of the IPG 14 isdisplayed in the lead display panel 104. In addition to allocatingcurrent to any of the electrodes of graphical leads 124 and 126, currentmay be allocated to the case 50 as an electrode.

Each of the electrodes 130 of the leads 124 and 126 may be individuallyselected, allowing the clinician to set the polarity and the magnitudeof the current allocated to that electrode 130. In the illustratedembodiment, electrode E15 is currently selected. Electrical current hasbeen allocated to three groups of electrodes respectively correspondingto three programming areas. Electrode group 130 a illustrates a singlecathode at electrode E2 to which is allocated 100% of the cathodiccurrent and two anodes at electrodes E1 and E3 to which are allocated25% and 75% of the anodic current, respectively. Electrode group 130 billustrates a single anode at electrode E7 to which is allocated 100% ofthe cathodic current and two anodes at electrodes E6 and E8 to which areallocated 50% and 50% of the anodic current, respectively. Electrodegroup 130 c illustrates a single cathode at electrode E10 to which isallocated 100% of the cathodic current and two anodes at electrodes E9and E11 to which are allocated 60% and 40% of the anodic current,respectively.

The parameter adjustment panel 106 includes a pull-down programming modefield 136 that allows the user to switch between a manual programmingmode, an e-troll programming mode, and a Navigation programming mode. Asshown in FIG. 7, the manual programming mode has been selected. In themanual programming mode, each of the electrodes 130 of the graphicalleads 124 and 126, as well as the graphical case 134, may beindividually selected, allowing the clinician to set the polarity(cathode or anode) and the magnitude of the current (percentage)allocated to that electrode 130 using graphical controls located in theamplitude/polarity area 138. In particular, a graphical polarity control140 located in the area 138 includes a “+” icon, a “−” icon, and an“OFF” icon, which can be respectively actuated to toggle the selectedelectrode 130 between a positive polarization (anode), a negativepolarization (cathode), and an off-state. An amplitude control 142 inthe area 138 includes an arrow that can be actuated to decrease themagnitude of the fractionalized current of the selected electrode 130,and an arrow that can be actuated to increase the magnitude of thefractionalized current of the selected electrode 130. The amplitudecontrol 142 also includes a display area that indicates the adjustedmagnitude of the fractionalized current for the selected electrode 130.Amplitude control 142 is preferably disabled if no electrode is visibleand selected in the lead display panel 104.

The parameter adjustment panel 106, when the manual programming mode isselected, also includes an equalization control 144 that can be actuatedto automatically equalize current allocation to all electrodes of apolarity selected by respective “Anode +” and “Cathode −” icons. Theparameter adjustment panel 106 also includes a pulse amplitudeadjustment control 146 (expressed in milliamperes (mA)), a pulse widthadjustment control 148 (expressed in microseconds (μs)), and a pulserate adjustment control 150 (expressed in Hertz (Hz)), which aredisplayed in all three of the programming modes. Each of the controls146, 148, 150 includes a first arrow that can be actuated to decreasethe value of the respective stimulation parameter and a second arrowthat can be actuated to increase the value of the respective stimulationparameter. Each of the controls 146, 148, 150 also includes a displayarea for displaying the currently selected parameter. In the illustratedembodiment, a pulse amplitude of 5 mA, a pulse width of 210 μs, a pulserate of 40 Hz have been selected.

As shown in FIG. 8, the e-troll programming mode has been selected. Inthis mode, the electrodes 130 illustrated in the lead display panel 104that were individually selectable and configurable in manual programmingmode are used for display only and are not directly selectable orcontrollable. The parameter selection panel 106 includes a steeringarray of arrows 152 that allows steering the electrical current up,down, left, or right. In the illustrated embodiment, the electricalcurrent is steered by panning a virtual multipole (i.e., the virtualmultipole is moved relative to the actual electrodes 26 without changingthe basic configuration (focus (F) and upper anode percentage (UAP)) ofthe virtual multipole), and computing the electrical amplitude valuesneeded for the actual electrodes 26 to emulate the virtual multipole.

In the e-troll programming mode, the parameter adjustment panel 106 alsoincludes an advanced tab 154, which when actuated, hides the leaddisplay panel 104 and provides access to a resolution control 156 and afocus control 158, as shown in FIG. 9.

The resolution control 156 allows changing the stimulation adjustmentresolution. In one embodiment, three possible settings of Fine, Medium,and Coarse may be chosen. The resolution control 156 has a “+” icon anda “−” icon that can be used to adjust the resolution. The resolutioncontrol 156 also includes a display element that graphically displaysthe current resolution level. When the resolution is set to Fine, eachchange caused by use of the steering array 152 makes less of a change tothe electrode configuration than when the resolution is set to Medium orCoarse. For example, panning of the virtual multipole with a Coarseresolution may displace the virtual multipole relative to the electrodearray 26 in steps equivalent to 10% of the electrode spacing, whereaspanning of the virtual multipole with a Fine resolution may move thevirtual multipole relative to the electrode array 26 in steps equivalentto 1% of the electrode spacing.

The focus control 158 allows changing the stimulation focus bydisplacing the anode(s) and cathode of the virtual multipole toward eachother to increase the focus, or displacing the anode(s) and cathode ofthe virtual multipole away from each other to decrease the focus. Thefocus control 158 has a “+” icon and a “−” icon that can be used toadjust the focus. The resolution control 158 also includes a displayelement that graphically displays the current focus level.

As shown in FIG. 10, the Navigation programming mode has been selected.As in the e-troll programming mode, in the Navigation programming mode,the electrodes illustrated in the lead display panel 104 that wereindividually selectable and configurable in manual programming mode areused for display only and are not directly selectable or controllable.The parameter selection panel 106 includes a steering array of arrows162 that allows steering the electrical current up, down, left, orright. In the illustrated embodiment, the electrical current is steeredby weaving one or more anodes around the cathode of the virtualmultipole as the cathode is displaced relative to the electrode array26, and computing the electrical amplitude values needed for theelectrodes 26 to emulate the virtual multipole.

Although particular embodiments of the present inventions have beenshown and described, it will be understood that it is not intended tolimit the present inventions to the preferred embodiments, and it willbe obvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present inventions. Thus, the present inventions are intended tocover alternatives, modifications, and equivalents, which may beincluded within the spirit and scope of the present inventions asdefined by the claims.

What is claimed is:
 1. An external control device for use with aneurostimulator and a remote control that is configured for use tomodify programming in the neurostimulator, the external control devicecomprising: control circuitry configured for programming theneurostimulator with at least one stimulation program, each of the atleast one program having a number of stimulation parameter sets, each ofthe number of stimulation parameter sets including parameter values formore than one neurostimulation parameter, wherein the control circuitryis configured for programming the remote control with a parameter setstatus for each of the number of parameter sets, the parameter setstatus determining whether the remote control has access to modifycorresponding ones of the number of parameter sets; a user interfaceconfigured for receiving input from a user, for displaying the number ofstimulation parameter sets for a corresponding stimulation program, andfor displaying a number of indicators corresponding to the number ofstimulation parameter sets, each of the number of indicators indicatingthe parameter set status for a corresponding one of the displayed numberof parameter sets for the corresponding stimulation program; and thecontrol circuitry further configured for, in response to input from theuser, selectively turning the indicator on or off for the correspondingone of the displayed parameter sets and programming the remote controlwith the parameter set status for the corresponding one of the parametersets according to whether the indicator is on or off.
 2. The externalcontrol device of claim 1, wherein the number of indicators include anumber of icons.
 3. The external control device of claim 2, wherein thenumber of icons includes a graphical depiction of a remote control toindicate that the remote control has access to the parameter set tomodify the stimulation program.
 4. The external control device of claim1, wherein the input from the user comprises actuating one of the numberof indicators.
 5. The external control device of claim 1, wherein theuser interface comprises one or more of a mouse, a trackball, atouchpad, and a joystick for receiving the input from the user.
 6. Theexternal control device of claim 1, wherein the user interface comprisesa digitizer screen for receiving the input from the user.
 7. Theexternal control device of claim 1, wherein the user interface isfurther configured for receiving additional input from the user, and thecontrol circuitry is further configured for, in response to theadditional input from the user, programming the neurostimulator with thestimulation parameter set.
 8. The external control device of claim 1,wherein the user interface is further configured for receivingadditional input from the user, and the control circuitry is furtherconfigured for, in response to the additional input from the user,programming the remote control with one of the number of stimulationparameter sets.
 9. The external control device of claim 1, wherein thecontrol circuitry is further configured for, in response to input fromthe user, selectively turning each of the indicators on or off.
 10. Theexternal control device of claim 9, wherein the control circuitry isconfigured for programming the stimulation program to include theplurality of stimulation parameter sets.
 11. A system, comprising: aneurostimulator programmed with at least one neurostimulation program,each of the at least one program including a plurality of stimulationparameter sets, each of the plurality of stimulation parameter setsincluding parameter values for more than one neurostimulation parameter;a remote control configured to be used to control the neurostimulator;and an external control device configured to program the remote controlwith the one or more stimulation parameter sets and program the remotecontrol with a corresponding parameter set status for each of theplurality of parameter sets, the parameter set status determiningwhether the remote control has access to modify corresponding ones ofthe plurality of stimulation parameter sets, the external control devicecomprising: a user interface configured to: receive input from a user;display the plurality of stimulation parameter sets for a correspondingstimulation program; and display a plurality of indicators correspondingto the plurality of stimulation parameter sets, each of the plurality ofindicators indicating the parameter set status for a corresponding oneof the displayed plurality of parameter sets for the correspondingstimulation program; and control circuitry configured to, in response toinput from the user, selectively turn the indicator on or off for thecorresponding one of the displayed parameter sets and program the remotecontrol with the corresponding parameter set status for thecorresponding one of the parameter sets according to whether theindicator is on or off.
 12. The system of claim 11, wherein the externalcontrol device is configured to store more than one stimulation program,each stimulation program including more than one stimulation parametersets.
 13. The system of claim 12, wherein the user interface isconfigured to receive a user selection for a selected stimulationprogram, and each stimulation parameter set for the selected stimulationprogram is simultaneously displayed along with the indicator for each ofthe displayed stimulation parameter sets.
 14. The system of claim 12,wherein each stimulation program includes four stimulation parametersets, wherein each of the four stimulation parameter sets for a selectedstimulation program is simultaneously displayed along with thecorresponding one of the plurality of indicators for each of thedisplayed stimulation parameter sets.
 15. The system of claim 11,wherein each of the displayed plurality of stimulation parameter setsinclude an amplitude value, a pulse width value and a frequency value.16. The system of claim 11, wherein the plurality of indicators includesan icon actuatable by the input from the user.
 17. The system of claim11, wherein the user interface is further configured for receivingadditional input from the user, and the control circuitry is furtherconfigured for, in response to the additional input from the user,programming the neurostimulator with the stimulation parameter set. 18.The system of claim 11, wherein the user interface is further configuredfor receiving additional input from the user, and the control circuitryis further configured for programming the remote control in response tothe additional input from the user.
 19. The system of claim 11, whereineach of the displayed plurality of stimulation parameter sets includevalues for: both amplitude and pulse width; or both amplitude andfrequency; or both pulse width and frequency.
 20. The system of claim11, wherein the displayed plurality of indicators includes an icon toindicate that the remote control has access to one of the plurality ofdisplayed parameter sets adjacent to the indicator to modify thestimulation program.